Associate QA Csc
Il y a 6 mois
Within Janssen R&D, a member of Johnson & Johnson's Family of Companies, we are recruiting a Quality Assurance Associate to strengthen the post-certification team The post-certification team is part of the Quality Assurance Clinical Supply Chain team and responsible to guarantee the quality and compliance of our investigational products after they have been certified for use in our clinical trials. We provide QA support for all activities related to our Investigational products at distribution depots, during transport and at the clinical sites: handling of deviations, temperature excursions, product quality complaints and support during audits and inspections by the Health Authorities.
In the Janssen Research & Development area we develop treatments that improve the health and lifestyles of people worldwide. R&D development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, pulmonary hypertension and reproductive medicine.
The QA-CSC team is looking for a QA CSC associate to join the team and perform the investigation of Product Quality Complaints and handle events during logístical activities.
**- Ensure that Complaints are reported, logged and investigated in a timely manner.
- Ensure that complaints are accurately investigated such that the internal and external customer expectations are met.
- Reach out to all stakeholders involved in the investigation (External Quality, Janssen manufacturing sites, Global Clinical Development).
- Ensure that adequate CAPA’s are defined for investigations with potential quality impact.
- Ensure that quality issues/complaints with potential impact on patients and/or product supply are accurately brought up.
- Proactively and continuously challenge the organizational performance and develop and implement improvements in organizational performance.
- Establish and maintain effective working relationships with the different business partners to ensure alignment of objectives and results.
- Define opportunities for process improvements and develops business cases and drives implementation.
**Qualifications**:
**Qualifications**:
**Job Qualifications**:
- University degree, scientific orientation (pharmaceutical, chemical, or biological sciences).
- Experience in pharmaceutical supply chain and/or Quality Assurance is an asset.
- Demonstrated ability to work independently while staying connected with key stakeholders.
- Operational Quality and/or Production related expertise is an asset.
- Product development expertise is an asset.
- Ability to work independently, to handle complexity, and to take ownership for deliverables, as well as flexibility and confirmed collaboration skills, are required
- Ability to quickly assimilate new technologies and product knowledge, perform risk assessment and develop action plans.
- In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures.
- Understands the business implications regarding quality positions and decisions
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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